(74 days)
The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.
Dukal Surgical Masks are pleated 3 – ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% melt blown polypropylene filter. Ear loops are made of soft latex free elastic loops. The nose piece for all Dukal Masks is a malleable aluminum wire. Masks with splash visors have an anti fog treated plastic shield attached to masks. All of the material used in the construction of the Dukal face masks are being used in currently marketed devices (see predicate information)
Here's a breakdown of the acceptance criteria and study information for the Dukal Surgical Mask, based on the provided 510(k) summary:
This device is a surgical mask, and the study described is a performance characteristic comparison against a predicate device and recognized standards, rather than a clinical study involving human readers or AI. Therefore, several sections of your request (MRMC study, standalone performance, training set details) are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the performance of the predicate device and the specified ASTM standards. The reported device performance is compared directly to these.
| Item | Acceptance Criteria (Predicate: Medicom K051291) | Reported Device Performance (Dukal Surgical Mask) | Test Method |
|---|---|---|---|
| Functional Properties | |||
| Inner Layer Raw Material | 100% Spun-bond polypropylene or medical grade tissue | 100% Spun-bond polypropylene or medical grade tissue | Raw material Specifications |
| Outer Layer Raw Material | 100% Spun-bond polypropylene or medical grade tissue (14gsm) | 100% Spun-bond polypropylene or medical grade tissue (16gsm) | Raw material Specifications |
| Middle Layer Raw Material | 100% melt blown polypropylene filter media | 100% melt blown polypropylene filter media | Raw material Specifications |
| Ear Loop Raw Material | Latex Free Elastic Loops and ties (38 gsm) | Soft latex free elastic loops and ties (40 gsm) | Raw material Specifications |
| Nose Piece Raw Material | Malleable aluminum wire | Malleable aluminum wire | Raw material Specifications |
| Plastic Shield Raw Material | ATFF-High Impact 0.10mm | ATFF-High Impact 0.10mm | Raw material Specifications |
| Mask Styles | Tie, Ear Loop and mask with fluid shield | Tie, Ear Loop and mask with fluid shield | N/A |
| Color | Blue | Blue | N/A |
| Layers | 3 | 3 | N/A |
| Performance Criteria | |||
| Fluid Resistance Performance (mmHg) | Pressure at 80mmHg, 19 out of 32 passed | 30 out of 32 passed | ASTM F1862-05 |
| Particulate Filtration Efficiency Performance (%) | 98.7% | 98.3% | ASTM2299 |
| Bacterial Filtration Efficiency Performance (%) | 99.8% | 99.9% | ASTM F2101-01, ASTM F2100-04 |
| Differential Pressure (Delta-P) (mmH2O/cm²) | 2.28 (ave) mmH2O/cm² | 2.28 (ave) mmH2O/cm² | ASTM F2101-01, MIL-M-36945C 4.4.1.1.1 Method 1 |
| Flammability class 1 | No Flame Spread Class 1 | No Flame Spread Class 1 | ASTM F2101-01, MIL-M-36945C 4.4.1.1.1 Method 1 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For the Fluid Resistance Performance test (ASTM F1862-05), the sample size was 32 units tested for both the predicate device and the Dukal mask.
- For other performance tests like Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability, a specific sample size is not explicitly stated in the provided text, but it is implied that sufficient samples were tested to obtain the reported percentages and average values according to the specified ASTM standards.
- Data Provenance: Not specified, but implied to be from laboratory testing conducted by Dukal Corporation for their device and likely from the predicate device's 510(k) submission for its data. This is a retrospective comparison against listed predicate device performance and standards. The country of origin of the testing is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This study involves objective performance testing of a physical product (surgical mask) against defined material specifications and ASTM standards, not the interpretation of medical data by experts. The "ground truth" for each parameter is established by the results of the standardized test methods.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this involves objective physical testing, not expert interpretation requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is not an AI/software device and no MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This is not an AI/software device. The device's performance is standalone in the sense that its physical properties are measured directly.
7. The Type of Ground Truth Used
The ground truth for the performance characteristics is established by:
- Recognized Performance Standards: Specifically, ASTM F1862-05, ASTM2299, ASTM F2101-01, ASTM F2100-04, and MIL-M-36945C. These standards define the acceptable methodology and often performance benchmarks.
- Predicate Device Performance: The performance data of the legally marketed predicate device (A.R. Medicom K051291) serves as a benchmark for substantial equivalence.
- Raw Material Specifications: For the composition of the mask layers, ear loops, nose piece, and plastic shield.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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510(k) Summary
SEP 1 8 2006
Device Trade Name: Non Sterile Surgical Mask
Name and Address of Manufacturer: Dukal Corporation 5 Plant Ave Hauppauge, NY 11788
Establishment Registration: 2435946
Contact Person: Patrick J. Lamb Vice President International Operations 5 Plant Ave. Hauppauge, NY 11788
Device Classification Name: Mask, Surgical
Classification Panel: Class II, §878.4040
Classification Advisory Committee: General and Plastic Surgery
Product Code: FXX
Recognized Performance Standard:
ASTM 2100-04 Refer to submission for applicable standards
Predicate Devices
- 510(k) Number 1. A.R. Medicom K051291
- ValuMax International (K040333
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| Intended Use: | The Dukal medical / surgical masks are indicated as aprotective nose and mouth covering for healthcare workersand patients involved in medical and surgical procedures.The masks are indicated in any procedure or situationwhere there is a risk of microorganism, body fluid andparticulate aerosol transfer. |
|---|---|
| 510(k) Statement: | A 510(k) statement for this device, as required by 21 CFR 93, isreplaced with this 510(k) summary. |
| Truthful and AccurateStatement: | A Truthful and accurate statement as required by 21 CFR§807.87(j) may be found in the submission in Exhibit A |
| Labeling: | Samples of proposed labeling may be found in the submission inExhibit B |
| Device Description: | Dukal Surgical Masks are pleated 3 – ply masks. Inner andouter layers are made of either medical grade tissue or100% spun-bond polypropylene. Middle layer is made of100% melt blown polypropylene filter. Ear loopsare made of soft latex free elastic loops. The nose piece forall Dukal Masks is a malleable aluminum wire. Masks with splashvisors have an anti fog treated plastic shield attached to masks. Allof the material used in the construction of the Dukal facemasks are being used in currently marketed devices (seepredicate information) |
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| Item | Test Method | Dukal | Medicom K051291 |
|---|---|---|---|
| Inner Layer | Raw materialSpecifications | 100% Spun-bondpolypropyleneor medical gradetissue (25 gsm) | Same |
| Outer Layer | Raw materialSpecifications | 100% Spun-bondpolypropylene ormedical gradetissue (16gsm) | 100% Spun-bondpolypropylene or medicalgrade tissue (14gsm) |
| Middle Layer | Raw materialSpecifications | 100% melt blownpolypropylenefilter media(25 gsm) | Same |
| Ear Loop | Raw materialSpecifications | Soft latex freeelastic loops andties(40 gsm) | Latex Free Elastic Loopsand ties38 gsm |
| Nose Piece | Raw materialSpecifications | Malleablealuminum wire | same |
| Plastic Shield | Raw materialSpecifications | ATFF-HighImpact 0.10mm | same |
| FluidResistancePerformance(mmHg) | ASTM F1862-05Pressure at 80mmHg | 30 out of 32passed | 19 out of 32 passed |
| ParticulateFiltrationEfficiencyPerformance(%) | ASTM2299 | 98.3% | 98.7% |
| BacterialFiltrationEfficiencyPerformance(%) | ASTM F2101-01ASTM F2100-04 | 99.9% | 99.8% |
| Item | Test | Dukal | Medicom K051291 |
| Differential Pressure(Delta-P)(mmH20/cm2) | ASTM F2101-01MIL-M-36945C4.4.1.1.1 Method 1 | 2.28 (ave)mmH2O/cm² | 2.28 (ave)mmH2O/cm² |
| Flammability class1 | ASTM F2101-01MIL-M-36945C4.4.1.1.1 Method 1 | No Flame SpreadClass 1 | No Flame SpreadClass 1 |
| Mask Styles | Tie, Ear Loop andmask with fluidshield | Tie, Ear Loop andmask with fluidshield | |
| Color | Blue | Blue | |
| Layers | 3 | 3 | |
Performance Characteristics
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Performace Characterics, con't
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Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2006
Mr. Patrick J. Lamb Vice President International Operations Dukal Corporation 5 Plant Avenue Hauppauge, New York 11788
Re: K061864
Trade/Device Name: Dukal Surgical Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: August 18, 2006 Received: September 13, 2006
Dear Mr. Lamb:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Lamb
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clara
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
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510(k) Number (if <nown): K061864
Device Name: Dukal Surgical Face Masks
Indications for Use:
The Dukal medical / surgical masks are indicated as a protective nose and mouth I his Dukar modiets and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.
meroorganison, boxs catalog numbers (these numbers can change with updated revisions to the catalog):
| Catalog | Face Mask Description | Model Type |
|---|---|---|
| Number | ||
| 1530 | Face Mask | Ear Loops |
| 1540 | Face Mask | Ties |
| 1560 | Face Mask | Fluid Shield with Ear Loop |
| 1570 | Face Mask | Fluid Shield with Ties |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A. Murphy, MD 3/18/04
on of Anesthesiology, General Hospital. uon Control, Dental Devices
Number: K 011 844
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.